If you have a heart condition, you may want to ask your
physician about participating in a cardiology clinical
trial. Participants in clinical trials try new medications,
treatments or devices that are years away from being
made available to the public. You will receive close
monitoring of your medical condition by a team of
physicians and nurses who are experts in the area that
is being researched. Thanks to the willingness of people
who volunteer to participate in clinical trials, major
life-saving medical advances have been developed.

What are clinical trials?
Clinical trials are research studies that evaluate new medications
and/or treatments. The same clinical study is
conducted at the same time in many hospitals, clinics
and physicians’ offices all over the country and, in some
cases, all over the world. Once the clinical trial is finished
and the results are evaluated and reported, the data helps
physicians prescribe better treatments and, sometimes,
discover cures for medical problems.

How safe are clinical trials?
Before a trial is tested on people, the medication, device
or treatment is studied extensively in various laboratories.
By the time the new treatment reaches the clinical
trial stage, there are many federal, medical and hospital
safeguards in place.

There are risks and side effects with almost any treatment
or drug. The same is true with those used in clinical
trials. In a clinical trial, the side effects and risks of
treatments and drugs are discovered, carefully examined
and reported.

Participants’ rights are always protected. Bridgeport
Hospital and all hospitals have an Institutional Review
Board (IRB) that is responsible for protecting the rights,
safety and well-being of patients involved in clinical
research. The IRB, which must approve all trials being
conducted at the hospital, consists of scientists, medical
personnel, and community members who have no
relationship to the clinical trial sponsors. The Food
and Drug Administration and the department of Health
and Human Services regulate the IRB and supervise
and regulate clinical trials. In all clinical trials, participants
are always free to withdraw at any time.

How can I join a clinical trial?
Because clinical trials are scientific studies, they have
strict participation criteria. These are typically based
on age, sex and medical condition requirements.

Who pays for the clinical trial?
There are no out-of-pocket costs to clinical trial participants.
Most clinical trials are sponsored by a pharmaceutical
company, a medical device manufacturer or the federal
government. Participants may be required to use personal
time to have blood tests or examinations. Occasionally, a
modest reimbursement is included.

Who conducts cardiology clinical trials?
At Bridgeport Hospital, the team includes two research
nurses, an assistant and a cardiologist (physician) who is
the Principal Investigator. The Principal Investigator is
responsible for the entire project and reports to the hospital’s
IRB, the trial sponsors and the federal government.

Do all participants get the medication or treatment being tested?
In a “double blind clinical trial,” one group of patients
receives the treatment that is being studied and another
group receives a placebo (a sugar pill or fake medication
or treatment). In addition, both groups receive the same
existing standard of care. The research team does not
know which group you are in.

It can take several years before a new drug or treatment
is deemed safe enough by the FDA to be approved for
use in the United States. There are several phases of
clinical trials that the new drug or treatment must pass
before it is allowed to be used by or prescribed for the
general public.

Phase One: The drug or treatment is tested to see if
it is safely absorbed, metabolized (broken down) and
eliminated (moved out) by the human body. Small
groups of healthy volunteers participate in this phase.
Their body’s reaction to the medication is closely
monitored by a physician and the clinical team.

Phase Two: The experimental treatment or drug is
given to carefully selected participants who are suffering
from the disease that the drug is designed to
treat. Several hundred participants are enrolled and
typically half will receive the usual treatment or drug
and half will receive the new treatment or drug.
Costs of the drugs, treatments and lab tests are generally
covered.

Phase Three: The new drug or procedure is measured
against the current best treatment. This is the
last stage before the FDA approves the drug for sale.
Two positive, well-controlled studies are required by
the FDA.

Late Summer Ratatouille8 servings

Ingredients

2 onions, sliced into thin rings

3 cloves garlic, minced

1 medium eggplant, cubed

2 zucchini, cubed

2 medium yellow squash, cubed

2 green bell peppers, seeded and cubed

1 yellow bell pepper, diced

1 chopped red bell pepper

4 roma (plum) tomatoes, chopped

1/2 cup olive oil

1 bay leaf

2 tablespoons chopped fresh parsley

4 sprigs fresh thyme

Salt and pepper to taste

Directions

Heat 11/2 tablespoons of the olive oil in a large pot
over medium-low heat. Add the onions and garlic
and cook until soft.

In a large skillet, heat 11/2 tablespoons of olive oil and
sauté the zucchini in one-layer batches until slightly
browned on all sides. Remove the zucchini and place
in the pot with the onions and garlic.

Sauté all the remaining vegetables, one layer at a time,
adding 11/2 tablespoons olive oil to the skillet each time
you add a new set of vegetables. Once each batch has
been sautéed, add them to the large pot.

Season with salt and pepper. Add the bay leaf and
thyme and cover the pot. Cook over medium heat
for 15 to 20 minutes.

Add the chopped tomatoes and parsley to the large pot
and cook for another 10-15 minutes. Stir occasionally.